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CAP Home > CAP Advocacy > CAP Proposal for Oversight of Laboratory Developed Test > LDT Oversight Should be Strengthened Frequenlty Asked Questions

  LDT Oversight Should be
  Strengthened:
  Frequently Asked Questions

 

Updated March 13, 2013

How are Laboratory Developed Tests (LDTs) regulated?
What is CAP doing to address the FDA’s intent to regulate LDTs and its components?
How would the CAP’s proposal work?
Who will determine the LDT classifications?
Which LDTs will be impacted?
Why are clinical validation requirements included in the CAP proposal?
How will the CAP proposal minimize delays caused by increased regulation?
Have CMS or FDA provided input into the CAP’s proposal for the oversight of LDTs?
What is the CAP’s position on the Burgess Legislation introduced in October 2011?
What are the main differences between the CAP’s LDT proposal and H.R. 3207?
When will the FDA release its LDT guidance?
Where can I get more information?

How are Laboratory Developed Tests (LDTs) regulated?

While the Food and Drug Administration (FDA) assumes authority for regulating LDTs, and is currently exercising enforcement discretion, it has indicated it will be increasing oversight of LDTs in the near future. Currently, the only oversight requirements governing LDTs are the laboratory requirements prescribed in the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The FDA has not yet made any changes, but stricter oversight of LDTs is widely anticipated.

On July 9, 2012, President Obama signed into law the bipartisan FDA user-fee bill, the Food and Drug Administration Safety and Innovation Act (FDASIA). For the next five years, the Act prohibits the FDA from issuing guidance on LDT regulation unless the Agency provides a 60-day advance notice to the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pension Committee of its intent to take such action.
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What is CAP doing to address the FDA’s intent to regulate LDTs and its components?

Over the past decade, the number, complexity, and importance of LDTs in diagnosing and treating disease have increased dramatically, creating the need for strengthened oversight that will ensure public safety.

Responding to this need, the CAP proposed a risk-based model employing a public-private partnership to address oversight of LDTs in an inclusive, systematic way. The CAP’s proposal relies on third-party accreditors and inspectors to oversee and monitor standards for low- and moderate-risk LDTs; high-risk LDTs would be reviewed directly by the FDA. The CAP presented this model to the FDA, and continues discussions with the Agency.
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How would the CAP’s proposal work?

CThe CAP proposes a public-private partnership to strengthen oversight of laboratory-developed testing through a three-tier ‘risk based’ system. This system will regulate claims about both analytic and clinical validity and provide for specific scientific and regulatory standards to be applied to all LDTs. Risk would be determined based on claims a laboratory makes about an LDT and its potential risk to patients.

The CAP believes optimum oversight will be achieved by applying a risk-based classification (low-, moderate-, or high-) to each LDT; strengthening CLIA accreditation standards on laboratories using low- and moderate-risk LDTs, and requiring FDA review of all high-risk LDTs.

High-risk LDTs are those LDTs intended to guide high-risk treatments or employ novel technology and/or statistical calculations that cannot easily be linked to existing test systems. In these cases, the CAP believes the FDA is best equipped to ensure necessary controls are applied to protect public health and safety.
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Who will determine the LDT classifications?

Under the CAP proposal, each laboratory would determine the LDT classification based on the FDA’s criteria for low-, moderate-, and high-risk tests. The determination would be verified by the laboratory’s certifier and/or accreditor.
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Which LDTs will be impacted?

FDA has indicated its intent to subject all LDTs to higher regulatory scrutiny. The CAP’s proposal would impact all LDTs developed within CLIA-certified laboratories that are used in patient management and have both of the following characteristics:

  • The test is performed by the clinical laboratory in which it was developed; and
  • The test is neither FDA-cleared nor FDA-approved.

The CAP proposal covers all types of LDTs—generic, molecular, conventional, and other.

However, CAP’s proposed changes would not apply to LDTs in use prior to adoption of the CAP proposal by FDA and Centers for Medicare and Medicaid Services (CMS) unless changes are made to their original use.
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Why are clinical validation requirements included in the CAP proposal?

The risk posed by many LDTs depends on how the LDT is intended to be used. Clinical validation requirements have been included in the CAP proposal to ensure that tests are accurately classified and that claims made about the accuracy or usefulness of a test are validated. As personalized healthcare and direct-to-consumer testing continues to grow and become more complex, it is important that LDTs are only labeled or promoted for uses that have been adequately verified for specific clinical purposes.
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How will the CAP proposal minimize delays caused by increased regulation?

The proposal has been structured to ensure that the majority of LDTs will still progress through the CLIA process and should have no or moderate effect on the timeline for implementation of these innovations. Other than performing clinical validation and an internal review process, laboratory reporting requirements for low-risk LDTs will be similar to those existing under CLIA, which already requires laboratories to notify the certifier and/or accreditor when they add a new test.
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Have CMS or FDA provided input into the CAP’s proposal for the oversight of LDTs?

Since the CAP formulated its proposed oversight model in 2009, it has had several meetings with the FDA and CMS, and the dialog has been productive. In addition, the CAP participated in several public meetings and town halls to discuss the topic with other stakeholders.

The CAP believes it is important to work with federal agencies and all stakeholders to continue to develop and refine this proposal. We are committed to ensuring that the quality standards and safeguards applied to LDTs evolve in step with technological advances.
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What is the CAP’s position on the Burgess Legislation introduced in October 2011?

The CAP welcomes any new approaches or proposals on how best to assess the analytical and clinical utility of LDTs in order to ensure patient safety. However, we believe the CAP proposal warrants our continued effort and support. “The Modernizing Laboratory Test Standards for Patients Act”, H.R. 3207, introduced by Rep. Michael Burgess, MD (R-TX)in October 2011, establishes firm registration requirements for every LDT in use now and in the future, but it does not provide the level of oversight the CAP feels is needed to ensure the safe use and validity of the tests. Moreover, it does not apply a risk-based classification system which CAP believes is critical to effective oversight.

Since announcing CAP’s proposal, the College has briefed federal and congressional officials, conducted outreach with multiple stakeholders within the pathology and laboratory community, and testified before numerous FDA-sponsored public forums on LDTs. The College will continue to work with all public and private stakeholders in pursuit of a consensus solution to the regulation of LDTs.
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What are the main differences between the CAP’s LDT proposal and H.R. 3207?

The CAP proposal relies on a three-tier ‘risk based’ system that would protect patients by instituting a graduated system of review based on a test’s potential risk to patients. The CAP believes optimum oversight would be achieved by applying a risk-based classification (low-, moderate-, or high-) to each LDT; strengthening CLIA accreditation standards on laboratories using low- and moderate-risk LDTs, and requiring the FDA’s review of all high-risk LDTs.


High-risk LDTs are those LDTs intended to guide high-risk treatments or employ novel technology and/or statistical calculations that cannot easily be linked to existing test systems. In these cases, the CAP believes the FDA is best equipped to ensure necessary controls are applied to protect public health and safety.

H.R. 3207 takes a different approach, with oversight responsibility resting solely with CMS, and all tests held to uniform submission and clinical validation standards. In addition, H.R. 3207 includes direct-to-consumer DNA tests in its definition of LDTs, and prohibits the consideration of clinical utility.
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When will the FDA release its LDT guidance?

TThe FDA has not indicated when the LDT guidance will be released. The Agency has said that the framework for the LDT oversight is complete and it is under review within the Administration. The Agency said it would release the framework as three guidance documents: Overall Regulatory Framework; Registry Requirements; and Description of the Synergies Between CLIA Regulations and FDA Quality System Regulation (QSR).
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Where can I get more information?

More information can be found on the CAP Advocacy homepage or contact Helena Duncan, CAP Assistant Director of Public Health and Scientific Affairs.
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